MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC; STENT, ILIAC

Model Number 20300

Device Problems Entrapment of Device (1212); Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2022

Event Type  malfunction  

Event Description

It was reported that stent froze on wire and inadvertent stent deployment occurred.Vascular access was obtained utilizing an antegrade puncture approached.The 90% stenosed target lesion was located in the mildly tortuous and non-calcified superficial femoral artery (sfa).A 6 x 40 x 120 epic stent was selected for treatment.While preparing the epic stent delivery system, it became entrapped on the amplatz guidewire.While attempting to remove the epic stent delivery system from the guidewire, the stent inadvertently deployed.A second 6 x 40 x 120 epic stent was selected for use.It was implanted in the sfa.However, an angiographic control showed under-expansion in the middle segments of this stent.A balloon was required to fully expand the implanted stent.A third epic stent was then selected for use.It was implanted in the sfa.However, angiographic imaging confirmed that this stent also did not fully expand.Another balloon was required to fully expand this stent.The procedure was then successfully completed.There were no patient complications.

Manufacturer Narrative

Initial reporter name and address: (b)(6).

Manufacturer Narrative

Device evaluated by mfr.: an epic ous vas 6x40x120 was received for analysis.This epic device is recommended for use with a 0.035-inch guidewire.During the product analysis a boston scientific 0.035-inch filterwire was successfully inserted through this device with no resistance experienced.The guidewire used by the customer was not returned for analysis.A visual and tactile examination identified accordion damage to the outer sheath of the device at more than one location.This type of damage is consistent with excessive force being applied to the device.The device was returned with the stent fully deployed from the delivery system.No issues or damage was noted with the stent.

Event Description

It was reported that stent froze on wire and inadvertent stent deployment occurred.Vascular access was obtained utilizing an antegrade puncture approached.The 90% stenosed target lesion was located in the mildly tortuous and non-calcified superficial femoral artery (sfa).A 6 x 40 x 120 epic stent was selected for treatment.While preparing the epic stent delivery system, it became entrapped on the amplatz guidewire.While attempting to remove the epic stent delivery system from the guidewire, the stent inadvertently deployed.A second 6 x 40 x 120 epic stent was selected for use.It was implanted in the sfa.However, an angiographic control showed under-expansion in the middle segments of this stent.A balloon was required to fully expand the implanted stent.A third epic stent was then selected for use.It was implanted in the sfa.However, angiographic imaging confirmed that this stent also did not fully expand.Another balloon was required to fully expand this stent.The procedure was then successfully completed.There were no patient complications.

• Brand Name: EPIC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16035481
• MDR Text Key: 307703135
• Report Number: 2124215-2022-51199
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20300
• Device Catalogue Number: 20300
• Device Lot Number: 0028292507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male